The watchdog offered a new assessment of the agency’s work to establish an active postmarket surveillance system to monitor the safety and efficacy of medical devices.

GAO report says FDA's pact with CISA on cybersecurity protocols for medical devices is five years old and needs to be updated.

The Department of Defense began working with Silicon Valley startup Zipline in 2018 through an Other Transaction Agreement.

The FDA’s new Medical Device Safety Action Plan builds on previous guidance around medical devices but also seeks to leverage private sector insight.

There's incredible diversity among medical device manufacturers, which raises some questions about what a threat information sharing would look like.

The Food and Drug Administration has put out draft guidance to help medical device makers manage the cyber vulnerabilities of connected pacemakers, insulin pumps and other networked…

An increasing number of medical devices, from pacemakers to insulin pumps, include components that could open them to cyber vulnerabilities. So will the Food and Drug Administration start taking into…